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Trial Name
ACCORD
Description
A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of 天发娱乐棋牌_天发娱乐APP-官网|下载 in Hospitalised Patients.
Objectives
Stage?1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with 天发娱乐棋牌_天发娱乐APP-官网|下载 in a screening stage.
Stage?2: To confirm the efficacy of candidate agents selected on the basis of evidence from Stage 1 in patients hospitalised with 天发娱乐棋牌_天发娱乐APP-官网|下载 in an expansion stage.
Trial Design
ACCORD is a seamless, Phase 2, adaptive, randomised controlled platform study, designed to rapidly test candidate agents in the treatment of 天发娱乐棋牌_天发娱乐APP-官网|下载. Designed as a master protocol with each candidate agent being included via its own sub-protocol, initially randomising equally between each candidate and a single contemporaneous SoC arm (which can adapt into 2:1). Candidate agents currently include bemcentinib, MEDI3506, acalabrutinib, zilucoplan and nebulised heparin. For each candidate a total of 60 patients will be recruited in Stage 1. If Stage 1 provides evidence of efficacy and acceptable safety the candidate will enter Stage 2 where a total of approximately 126 patients will be recruited into each study arm sub-protocol. Enrollees and outcomes will not be shared across the Stages; the endpoint, analysis and sample size for Stage 2 may be adjusted based on evidence from Stage 1. Additional arms may be added as new potential candidate agents are identified via candidate agent specific sub-protocols.
Trial Status
Open to recruitment.
Population
ACCORD will include several different potential treatments. These include new and existing anti-viral drugs, drugs which affect the immune system and drugs which target inflammatory molecules. The patient population will vary depending on the treatment.
Other
EudraCT 2020-001736-95, registered 28th April 2020.
Trial Team
The ACCORD steering committee is chaired by Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of 天发娱乐棋牌_天发娱乐APP-官网|下载 with? Professor Gareth Griffiths, SCTU as a member. It also includes a team of clinical and scientific experts, representatives of the trial sponsor and the UKRI, and representatives from the trial sites and delivery group.
Contact Information
Email: accord@uhs.nhs.uk
Essential Documentation
All documentation for the ACCORD trial can be accessed via www.accord-trial.org
Other Media
All documentation for the ACCORD trial can be accessed via www.accord-trial.org